'Black box' warning on antidepressants vastly reduced lawsuits against Eli Lilly, others

People committing horrific acts while on antidepressants.

Such news used to be common. Like the Wyoming man on Paxil who in 1998 fatally shot his wife, daughter, granddaughter and then himself. Or the 17-year-old Hawaii boy on Prozac who went in his bedroom in 1999 and hanged himself. Or the middle-aged Pennsylvania woman who took Prozac for weight loss in 1997 and three weeks later slit her wrists and overdosed on a drug that damaged her brain.

Today, antidepressant use is as widespread as ever, with 2012 sales topping $8 billion. And it's not as though such violent reactions no longer happen. But there's a reason why you are less likely to hear about such incidents.

People just aren't suing anymore. The days of the big-bucks lawsuits that generated so much attention on the issue — and caused such angst for companies such as Eli Lilly and Co. — have pretty much subsided.

A once-fertile field of litigation for trial lawyers — Lilly and other drugmakers once faced hundreds of lawsuits over their antidepressants — has pretty much dried up. Only a few wrongful-death or injury cases tied to antidepressants remain in U.S. courts.

The reason is largely due to a decision made by the Food and Drug Administration 10 years ago this fall that required drug makers to include a "black box" warning that says that antidepressants can cause suicidal behavior in adolescents. In 2007, the warning was broadened to include young adults.

That marked a big change from the flat refusal by drug makers to admit their antidepressants might cause some people to act violently. It also marked a big change for trial attorneys.

In essence, their long litigation battle with drug companies was over. They could no longer make a good case in court that drug makers weren't disclosing a lethal side effect of their antidepressants — and that's where the money was.

Houston trial lawyer Andy Vickery, who built his 40-year legal career on representing plaintiffs in antidepressant suicide cases, said the black box warning spelled a dwindling caseload for him.

He still calls drug makers "fire-breathers" (his main foe was Lilly and its antidepressants Prozac and Cymbalta), but he's barely battling them these days. He settled his last Lilly case last year, involving a South Dakota boy who committed suicide on Christmas Eve 2004, four weeks after taking Cymbalta. He has just two other cases left in court. Both involve Forest Laboratories and its drug Lexapro.

The story is much the same at the Los Angeles law firm Baum Hedlund Aristei & Goldman, the other longtime litigator in the antidepressant field.

Since 1990, the firm has handled 140 antidepressant-suicide cases. The first was on behalf of the widow of rock and roll singer Del Shannon, who committed suicide while on Prozac. Today, Baum Hedlund has just one active antidepressant-suicide case. It involves a Chicago attorney who jumped in front of a train while on Paxil. The firm has turned its attention to other drug litigation and transportation cases, said Bijan Esfandiari, an attorney at the firm.

It also hasn't helped trial lawyers that the most widely used antidepressants behind the wrongful death and injury lawsuits have all gone generic. Prozac, the first antidepressant to be targeted by trial lawyers, lost its U.S. patent in 2001, with Zoloft and Paxil following five years later.

Under U.S. law, generic drug makers enjoy special protections that make it hard to successfully sue them for wrongful death and injury. The protections are given on the grounds that, because the generic companies sell copies of drugs they didn't develop and test, they can't be deemed responsible for any side effects

Lilly, once the focus of antidepressant litigation, now is largely removed from it. Its two best-sellling antidepressants, Prozac and Cymbalta, are both off-patent and have faded in significance for the company.

A company spokesman, Scott MacGregor, acknowledged that lawsuits over Prozac's and Cymbalta's side effects "tapered off" as the 2004 black box warning took effect.

But if the 10-year-old black box warning has quieted the litigation over antidepressants and violent acts, it hasn't ended the debate over the causative link. Or whether the warning itself was a good thing.

It's been a long debate. Since Prozac's launch in the late 1980s, Lilly opposed any warning about suicidal effects. The company attributed suicidal behavior among depressed patients to the illness itself.

Only two of the hundreds of Prozac lawsuits ever made it before juries — and Lilly proved victorious both times. In a case in Kentucky in 1994, a jury sided with Lilly, but the company had secretly reached a reported $25 million settlement that was not disclosed to the judge before the verdict was reached. And in a case in Hawaii in 1999, Lilly again prevailed but settled after the plaintiff appealed.

Reflecting on the black box warning, company spokesman MacGregor said, "We trust the FDA's regulatory actions (were) motivated by factors other than lawsuits and the unsupported claims of plaitiffs' lawyers."

An article in the June edition of the London medical journal The BMJ concludes that the black box warning might have backfired. Since the warning came out, the trend of antidepressant use among U.S. teens and young adults has fallen, and there's been a corresponding increase in suicides as measured by drug poisonings, according to the article.

The article has been roundly critiqued. Critics question the limited data set of patients used in the article and the way antidepressant use was measured, among other things.

The medical director of the National Alliance on Mental Illness, Dr. Ken Duckworth, who was the first person to testify before the FDA's advisory panel at its emotion-filled 2004 hearing on the black box warning, said he worried then about the impact of such a label, the most serious warning the FDA gives for drug side effects. Duckworth said he thought a boxed label warning might scare people away from using antidepressants and open the door to a rise in suicides among people who avoided treatment for severe depression.

"I was afraid it would have a chilling effect on antidepressant use," he said. "That appears to be what happened."

Dr. Jerald Kay, chairman of the psychiatry department at Wright State University and a doctor at its Boonshoft School of Medicine in Dayton, Ohio, said he has been a longtime skeptic of the black box warning.

"I never felt like it was based on very sound scientific evidence," he said. "A lot of us felt a lot of this (concern over suicidal behavior) was kind of trumped up."

Nevertheless, Vickery, now 66 and working just three days a week at his law practice, sees the black box warning as vindication of sorts for his long legal battles with pharmaceutical companies. Most of Vickery's dozens of cases ended in secret, out-of-court settlements. That's typical of many of the hundreds of cases filed against antidepressant makers. The payouts to settle the cases likely will never be known, but they are in the tens or perhaps hundreds of millions of dollars.

Vickery holds the distinction of being the only trial lawyer to win an antidepressant suicide case before a jury. He won a $6.5 million judgment against GlaxoSmithKline in a 2001 trial involving the Wyoming man who shot his family members. The case was later settled after Glaxo appealed.

"I honestly believe if not for that win in Wyoming, we would have never seen the (black box) warnings we've got today," Vickery said.

As for the warnings, even though they undercut his ability to sue drug makers over the antidepressant-violence link, Vickery said he's still happy to see them.

"I can tell you with a great deal of confidence there are people who are alive now because of the warnings. Because doctors do know (about the suicide risk), people's lives are being saved."

British psychiatrist Dr. David Healy, an expert witness in court for Vickery in some of his cases, said he thinks the Houston attorney and other plaintiffs' lawyers discovered evidence through their lawsuits about harmful side effects from antidepressants that helped persuade the FDA and its advisory panels to pass the black box warnings.

"Andy was part of a very small group of people who ultimately triggered the access to data debate we have now — making people aware just how much of the medical literature is ghostwritten and how much of the data, especially (drug) adverse event data, is hidden, and how much pharma companies have targeted children. In any reasonable universe, Andy would be honored widely by a range of groups such as APA (American Psychiatric Association)," Healy said in an email.

As the litigation ends, the venue for much of the debate over the effects of antidepressants has shifted from the courts to public websites.

Laurie Yorke, a registered nurse from Clark, N.J., runs paxilprogress.org, for people to share their experiences taking antidepressants. Yorke sued Paxil maker GlaxoSmithKline in 2005 on behalf of her teen son Ryan after he suffered a mental breakdown while taking Paxil. Her suit was settled out of court for terms she said she can't disclose.

"It gets millions of hits a month," she said of her nonprofit website. "I talk to people all over the world."

Even after decades of litigation and studies by the dozens, Yorke said she is convinced that the side effects of antidepressants continue to be unclear to the public. With experts divided even on the question of whether the black box warning is needed, Yorke said, websites like hers that let people share their personal experiences might be the best way for many people to assess the usefulness and safety of the brain chemical-altering pills that are prescribed to millions.

Call Star reporter Jeff Swiatek at (317) 444-6483. Follow him on Twitter: @JeffSwiatek.